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38

NCCN Guidelines for Patients

®

:

Kidney Cancer, Version 1.2017

4

Overview of cancer treatments

Clinical trials

Clinical trials

New tests and treatments aren’t offered to the public

as soon as they’re made. They need to be studied

first. New uses of tests and treatments also need to

be studied.

A clinical trial is a type of research that studies a

test or treatment. Clinical trials study how safe and

helpful tests and treatments are. When found to

be safe and helpful, they may become tomorrow’s

standard of care. Because of clinical trials, the tests

and treatments in this book are now widely used to

help patients.

Tests and treatments go through a series of clinical

trials to make sure they’re safe and work. Without

clinical trials, there’s no way to know if a test or

treatment is safe or helpful. Clinical trials are done in

a series of steps, called phases. The four phases of

clinical trials are described next using the example of

a new drug treatment:

†

†

Phase I

trials aim to find the best dose and way

to give a new drug with the fewest side effects.

If a drug is found to be safe, it will be studied in

a phase II trial.

†

†

Phase II

trials assess if a drug works for a

specific type of cancer. They are done in larger

groups of patients with the same type of cancer.

†

†

Phase III

trials compare a new drug to the

standard treatment. These are randomized,

meaning patients are put in a treatment group

by chance.

†

†

Phase IV

trials test new drugs approved by the

FDA (U.S.

F

ood and

D

rug

A

dministration) to

learn about short-term side effects, long-term

side effects, and safety. They involve many

patients with different types of cancer.

Joining a clinical trial has benefits. First, you’ll have

access to the most current cancer care. Second, you

will receive the best management of care. Third, the

results of your treatment will be carefully tracked.

Fourth, you may help other patients with cancer.

Clinical trials have risks, too. Like any test or

treatment, there may be side effects. Also, new

tests or treatments may not work better than current

treatments. Another downside may be that paperwork

or more trips to the hospital may be needed.

To join a clinical trial, you must meet the conditions

of the study. Patients in a clinical trial often have a

similar cancer type and general health. This helps

ensure that any response is because of the treatment

and not because of differences between patients.

You also must review and sign a paper called an

informed consent form to join a clinical trial. This form

describes the study in detail, including the risks and

benefits.

Ask your treatment team if there is an open clinical

trial that you can join. There may be clinical trials

where you’re getting treatment or at other treatment

centers nearby.